Radiolucent chest assembly

ABSTRACT

A wireless monitoring system and, more particularly, a wireless monitoring system for detecting and transmitting physiological data. The present invention detects physiological data relating to a patients cardiac activity and respiration rate and transmits the data to a remote base station via telemetry. The base station processes the data so that the data can be displayed by an ECG monitor.

RELATED APPLICATIONS

The application is a continuation and claims the benefit of the filingdate pursuant to 35 U.S.C. § 120 of application Ser. No. 10/439,356filed on May 16, 2003 which in turn is a continuation-in-part of andclaims the benefit of the filing date pursuant to 35 U.S.C. § 120 ofapplication Ser. No. 09/998,733, for a WIRELESS ECG SYSTEM, filed Nov.30, 2001, which in turn, is a continuation-in-part of and claims thebenefit of the filing date pursuant to 35 U.S.C. § 120 of applicationSer. No. 09/908,509, for a WIRELESS ELECTROCARDIOGRAPH SYSTEM ANDMETHOD, filed Jul. 17, 2001, the disclosure and content of which ishereby incorporated by reference in its entirety. This application alsoclaims the benefit of the filing date pursuant to 35 U.S.C. § 120 ofApplication Ser. No. 60/392,882, for a FASTENER ASSEMBLY, filed Jul. 1,2002, the disclosure and content of which is hereby incorporated byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a wireless monitoring system and, moreparticularly, to a wireless monitoring system for monitoringphysiological data.

BACKGROUND OF THE INVENTION

An electrocardiograph (ECG) system monitors heart electrical activity ina patient. Conventional ECG systems utilize electrodes or sensors placedon a patient in specific locations to detect electrical impulsesgenerated by the heart during each beat. Typically, these electricalimpulses or signals are detected by and directly transferred from thesensors or electrodes to a stationary ECG monitor via multiple cables orwires. The ECG monitor performs various signal processing andcomputational operations to convert the raw electrical signals intomeaningful information that can be displayed on a monitor or printed outfor review by a physician.

Doctors have used ECG systems to monitor heart activity for decades.Currently, there are several different systems that use ECG signals tomonitor heart activity. These systems, however, are generally stationaryand are not developed or suitable for portable use. While portabletelemetry systems exist, they are not a direct replacement forstationary ECG monitors. Moreover, because conventional systems usemultiple cables or wires, and are cumbersome and uncomfortable for thepatient, and require a significant amount of set up time. Thus, a needexists for a wireless ECG system that solves the aforementionedproblems. The present invention fills this need.

Furthermore, in both traditional wired systems and wireless systems,portions of the conventional electrodes or sensors that connect to thecables, wires, or chest assemblies are not standardized. In other words,the metal snap pieces or metal tabs that connect to the female portionsof the cables, wires, or chest assemblies come in various sizes, shapesand configurations. Accordingly, many of the conventional electrodes orsensors are not compatible for use with many of the wires, leads, orchest assemblies used in physiological data collections systems.

To solve this problem, many conventional wired systems utilize springloaded, female snap pieces, which are compatible with many differentelectrodes or sensors having male snap pieces or metal tabs. Thosespring loaded, female snap pieces, however, are substantially moreexpensive than other conventional female snap pieces. Nevertheless,because the increased cost of the spring loaded, female snap pieces canbe amortized over the life of the cable or lead set, the increased costsof those snap pieces are not a major consideration for conventionalwired systems.

However, the increased costs of those female snap pieces cannot beamortized over the life of a chest assembly used in a typical wirelessor telemetry system since the chest assemblies used in such systems aregenerally discarded after each patient use. Accordingly, the increasedcost of those spring loaded, female snap pieces make them unsuitable foruse with a chest assemblies used in a wireless or telemetry system.

To avoid the incompatibility problems with conventional electrodes orsensors and the increased cost associated with spring loaded, femalesnap pieces, some wireless or telemetry systems use chest assemblieshaving integrated electrodes or sensors. A major disadvantage to suchchest assemblies, however, is that those chest assemblies must behermetically packaged to preserve the integrity of the aqueous silverchloride gel on the electrodes integrally connected to those chestassemblies. As a result, the cost of such chest assemblies issignificant. Because those chest assemblies are designed to be disposedof after each patient use, the increased cost of those chest assembliesmake them cost inefficient.

In addition, the spring loaded, female snap pieces and the metal snapstypically used with conventional electrodes or sensor are typicallyconstructed of metal and are not radiolucent. Consequently, those snappieces and metal snaps show up clearly on x-rays and other imagingprocedures. Transparency to hospital imaging systems such as x-ray orfluoroscopes is desirable in many medical procedures such as are carriedout in cardiac catheterization labs where conventionalelectrocardiograph electrodes and wires may obscure the view of internalblood vessels. Radiolucent electrodes are known in the art and are soldby companies such as Kendle and 3M. Non-disposable radiolucent electrodeleads exist but cost in excess of a thousand dollars per radiolucentlead set.

Accordingly, there exists a need for a fastener assembly that is capableof connecting a disposable chest assembly to any conventional electrodeor sensor, cost efficient, radiolucent and easy to use. The presentinvention fills this need.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to a wireless ECG system that isuniversally compatible with existing or conventional ECG monitors. TheECG system generally comprises a chest assembly, a body electronicsunit, and a base station. The chest assembly connects to electrodesspecifically located on a patient's body for detecting electricalsignals from the patient's heart. The electrical signals are detected bythe chest assembly—thus, providing up to a “7 lead” analysis of theheart. Alternatively, the chest assembly can be augmented with aprecordial assembly that connects to electrodes specifically located onthe patient's body—thus, providing a “12 lead” analysis of the heart.

The electrical signals are transmitted through the chest assembly and/orthe precordial assembly to the body electronics unit, which removablysecures to the patient via an armband. The body electronics unittransmits the electrical signals to the base station via radiotransmission. The base station contains terminals configured to attachto standard lead wires or cable. The base station transmits theelectrical signals to a conventional ECG monitor via the standard leadwires or cables. In turn, the ECG monitor processes or transforms theelectrical signals into meaningful information that can be displayed onthe ECG monitor for review by a physician.

The ECG system eliminates the wires that ordinarily tether an ECG patentto an ECG monitor by replacing conventional wires with a radio link. Thepresent invention is lightweight and portable—thereby providingincreased comfort and mobility to the patient. In addition, the presentinvention requires decreased setup times and is more convenient forhealth practitioners to use than conventional ECG systems. In addition,to collecting and transmitting ECG signals, the present invention iscapable of collecting and transmitting other physiological data. Forexample, the body electronics unit is capable of transmitting and thebase station is capable of receiving and processing physiological datapertaining to a patient's pulse, respiration rate, heart rate,temperature, blood pressure, EEG signals, and pulse oximeter signals, orthe like.

In addition, the present invention relates to a fastener assembly for aconnecting a conventional electrode or sensor to a system for collectingphysiological data from a patient. More particularly, the fastenerassembly electrically connects the conventional electrode or sensor toan electrically conductive element or trace within the lead assembly.The electrically conductive element may be silver epoxy or any othersuitable electrically conductive adhesive. The fastener assemblyconnects the electrodes or sensors to the electrically conductiveelement or trace at an electrode connection point. At the electrodeconnection point, the lead assembly has an aperture therethrough formedfrom a star cut pattern. The star cut pattern could be die cut, punched,laser cut or formed by other known means. The star cut pattern definesflaps that mechanically hold the electrode or sensor in the aperture andprovide an electrical connection between the electrically conductiveelement or trace and the electrode or sensor upon insertion of theelectrode or sensor in the aperture. Further, at each electrodeconnection point, the fastener assembly includes an electrode housingsecured to the non-patient side of the lead assembly. The electrodehousing is constructed of an elastomeric material bonded to the backsurface of the lead assembly and contains a female void for receivingand removably securing a male portion of the electrode or sensor. Inaddition, at each electrode connection point, the chest assembly mayoptionally include an electrically conductive, adhesive layer forremovably securing the electrode or sensor to the chest assembly andproviding enhanced electrical connection between the electricallyconductive element or trace and the electrode or sensor upon insertionof the electrode or sensor though the aperture.

In operation, the male portion of the electrode or sensor is insertedthrough the aperture starting at the patient side of the lead assembly.The flaps formed by the aperture are deflected as the male portion ofthe electrode or sensor is inserted into the aperture. The resilience ofthe flaps cause the flaps to wipe against the male portion andmechanically hold the electrode or sensor in the aperture definedbetween the flaps. After passing though the aperture, the male portionis inserted into the female void contained in the electrode housing. Thefemale void receives the male portion of the electrode or sensor andremovably secures the electrode or sensor to the chest assembly. Theelastomeric property of the electrode housing allows the female void toreceive and secure electrodes or sensor having different shapes andsizes. The electrode or sensor is inserted into the aperture until thecontact portion of the electrode or sensor (such as a male snap post)abuts or contacts the electrically conductive element in the leadassembly. The electrically conductive element in the lead assembly makescontact with the electrode or sensor and creates an electrical linkbetween the electrode or sensor and the electrically conductive elementor trace in the lead assembly. Optionally, electrically conductiveadhesives may be added to either the lead assembly or the electrodehousing to enhance the electrical connection. The fastener assembly ofthe present invention may be used to connect conventional electrodes orsensors to both traditional wired systems and wireless systems forcollecting physiological data from a patient.

These as well as other novel advantages, details, embodiments, features,and objects of the present invention will be apparent to those skilledin the art from the following detailed description of the invention, theattached claims and accompanying drawings, listed herein below which areuseful in explaining the invention.

BRIEF DESCRIPTION OF THE DRAWING

The foregoing aspects and many of the advantages of the presentinvention will become readily appreciated by reference to the followingdetailed description of the preferred embodiment, when taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of an exemplary embodiment of the ECGsystem;

FIG. 2 is a cross sectional view of the chest assembly and theprecordial assembly;

FIG. 2A is a cross sectional view of an exemplary embodiment of thechest assembly;

FIG. 3 is a top view of an exemplary embodiment of the chest assembly;

FIG. 3A depicts another exemplary embodiment of the chest assembly andthe precordial assembly;

FIG. 4 is a top view of an exemplary embodiment of the precordialassembly;

FIG. 5 is a perspective view of an exemplary embodiment of the bodyelectronics unit;

FIG. 6 is a top view an exemplary embodiment of the assembly connectors;

FIG. 7 is a perspective view of an exemplary embodiment of the bodyelectronics unit;

FIG. 7A is an exemplary embodiment of the user interface of theelectronics body unit;

FIG. 7B is a block diagram of an exemplary of the respiration rate inputcircuit;

FIG. 7C is a block diagram of an exemplary embodiment of the currentsource circuit;

FIG. 8 is a block diagram of an exemplary embodiment of the transmitter;

FIG. 9A is a perspective view of an exemplary embodiment of the basestation used in conjunction with the token key;

FIG. 9B depicts the body electronics unit used in conjunction with thetoken key;

FIG. 10 is a perspective view of an exemplary embodiment of the basestation;

FIG. 11 is a perspective view of an exemplary embodiment of the basestation;

FIG. 11A is an exemplary embodiment of the user interface of the basestation;

FIG. 12 is a block diagram of an exemplary embodiment of the receiver;

FIG. 12A is a block diagram of an exemplary embodiment of therespiration rate input circuit;

FIG. 12B is a block diagram of an exemplary embodiment of therespiration rate network;

FIG. 13 is a perspective view of an exemplary embodiment of the basestation;

FIG. 14 is an exemplary embodiment of the adaptor assembly;

FIG. 15 is another exemplary embodiment of the adaptor assembly;

FIG. 16 is another exemplary embodiment of the adaptor assembly;

FIG. 17 is a flow chart of an exemplary embodiment for operation of theECG system;

FIG. 18 depicts the order and timing in which the body electronics unitsamples the signal channels;

FIG. 19 depicts the formation of the raw data set and the snapshot dataset after sampling the signal channels;

FIG. 20 depicts the averaging process for the raw data set beforetransmission of the data set to the base station;

FIG. 21 depicts the filtering process for the raw data set conductedafter the averaging process and before transmission of the data set tothe base station;

FIG. 22 depicts the raw data set and the snapshot data set packaged intoraw data packets and snapshot data packets;

FIG. 23 depicts the FIR interpolation process for the ECG data packets;

FIG. 24 depicts the duplication process conducted after the FIRinterpolation process;

FIG. 25 depicts the restoration of the pacemaker pulse in the ECG datastream;

FIG. 26 depicts the order and timing in which the base station plays outthe signal channels;

FIG. 27 is a block diagram of the Bluetooth radio system used with thepresent invention;

FIG. 28 is a cross sectional view of an exemplary embodiment of chestassembly having an electrode housing;

FIG. 29 is a cross sectional view of an exemplary embodiment of chestassembly having an electrode housing and coupled to an electrode;

FIG. 30 is a cross sectional view of another exemplary embodiment ofchest assembly having an electrode housing and coupled to an electrode;

FIG. 31 is a cross sectional view of another exemplary embodiment ofchest assembly having an electrode housing and coupled to an electrode;and

FIGS. 32A-E depict exemplary embodiments of an aperture formed in achest assembly for receiving an electrode.

DESCRIPTION OF THE PREFERRED EMBODIMENT

For a better understanding of the present invention, reference may behad to the following detailed description taken in conjunction with theappended claims and accompanying drawings. Briefly, the presentinvention relates to a wireless, portable ECG system. Referring to FIG.1, the ECG system 10 comprises a chest assembly 12, a body electronicsunit 14, and a base station 16.

The chest assembly 12 is a one-piece flexible circuit that connects aplurality of electrode connectors 18. The electrode connectors 18 areconfigured to connect to electrodes 20 or electrically conductiveadhesives. Preferably, the electrode connectors 18 have snap terminalsthat connect to electrodes 20 having snap terminals. Each electrodeconnector 18 connects to an electrically conductive element or trace fortransmitting electrical signals. The electrically conductive elements ortraces run along the chest assembly 12 and connect to a chest assemblyconnector 21. Alternatively, the chest assembly 12 may be constructedwith electrode conductors, instead of electrode connectors. In such anembodiment, each electrode conductor will have a flat, conductivesurface. Electrodes having flat conductive surfaces may be coupled tothe electrode conductors via a suitable adhesive. Thus, electrodes canbe attached to the chest assembly by “sticking” an electrode to eachelectrode conductor.

Referring to FIG. 2, the chest assembly 12 may have outer layers 22, 24that are constructed of a lightweight and reasonably moisture resistantmaterial, such as DuPont Sontara® or other suitable fabric. The chestassembly 12 may be constructed with only one outer layer or no outerlayers without departing from the spirit and scope of the invention.Moreover, if the chest assembly is constructed with just one outerlayer, that outer layer can be on either side of the chest assembly 12without departing from the spirit and scope of the invention. Adhesivelayers 26, 28 secure insulating layers 30, 32 to the outer layers 22, 24respectively. Insulating layers 30, 32 may be constructed of Mylar®(polyester) film or other suitable insulating material. Adhesive layers34, 36 secure the insulating layers 30, 32 to a base layer 38. The baselayer 38 is preferably constructed of Mylar film and has a first side 40and a second side 42. The electrically conductive elements or tracesthat connect to the electrode connectors 18 may be located on the firstside 40 of the base layer 38. One such conductive element or trace isshown at 39. A shielding layer 44 for reducing any external inferencesor radio frequency noise with the chest assembly 12 may be located onthe second side 42 of the base layer 38. The shielding layer 44 may beconstructed of single or multiple layers of dielectric, or electricallyor magnetically conductive material. Of course, the chest assembly 12may be constructed without a shielding layer 44 without departing fromthe spirit and scope of the invention. Typically, a shielding layer 44will be necessary in “noisy” environments. The shielding layerpreferably comprises an X-patterned grid. The back of the electrodeconnector 18 may also be covered with Mylar to further insulate thechest assembly 12 and prevent an externally applied electric potentialfrom entering the ECG system.

Referring to FIG. 2A, the chest assembly 12 may be constructed with anadhesive sheet 45 that partially or completely covers the chest assembly12. The electrode connectors 18 may be sandwiched between the adhesivesheet 45 and the outer layer 24 of the chest assembly 12. Alternatively,electrode conductors may be used instead of electrodes connectors 18.Preferably, the adhesive sheet 45 is constructed of polymers that haveisotropic electrical conductive properties and/or anisotropic electricalconductive properties such that the regional specific impedance throughthe adhesive sheet 45 is less than in a laterally oriented dimensiondirection. The polymers are preferably hydropolymers, which areelectrically conductive, relatively nonirritating to a patient's skin,and demonstrate excellent adhesive qualities.

Suitable hydropolymer sheets for use with the present invention areavailable from Promeon of Boston, Mass., under the product designationRG-60 Series Hyrogels. In another exemplary embodiment, the adhesivehaving isotropic electrical conductive properties and/or anisotropicelectrical conductive properties could be applied to the electrodeconnector 18 or the electrode conductor just prior to the attachment ofthe electrode 20 to the chest assembly 12. The adhesive could be appliedbetween the electrode connector 18 (electrode conductor) and theelectrode 20 or to the side of the electrode 20 that contacts orconnects to the patient. In such an embodiment, the chest assembly 12would not be manufactured with an adhesive sheet 45. Instead, the healthcare provider would apply the adhesive to the electrode connector 18(electrode conductor) and/or electrode 20 just prior to attaching thechest assembly 12 to the patient.

In an alternative embodiment, the chest assembly 12 may be constructedto connect to any conventional electrode or sensor. More specifically,as shown in FIGS. 28-29, at each point (ie., connection point 400) wherean electrode or sensor connects to the chest assembly 12, portions ofthe layers of the chest assembly 12 that reside on the patient side areremoved or are not applied during manufacture and the first side 40 ofthe base layer 38 containing the electrically conductive element ortrace 39 is exposed. At each electrode or sensor connection point 400,the chest assembly 12 optionally includes an electrically conductivelayer 402 adhered to the electrically conductive element or trace 39.The optional electrical adhesive layer 402 may be a layer of silverepoxy or other suitable electrically conductive, adhesive materialcapable of adhering or securing the electrode or sensor to the chestassembly 12 and providing an electrical link between the electrode orsensor with the electrically conductive element or trace 39.

In addition, at each electrode or sensor connection point 400, the chestassembly 12 includes an aperture 404 formed therethrough. As shown inFIG. 32A, the aperture 404 may be defined by a star cut pattern in theform of an asterisk with six legs 406 cut through each layer of the leadassembly 12. Each corresponding adjacent legs 406 define a flap 408. Theaperture 404 may be cut in various shapes and configurations withoutdeparting from the scope and spirit of the invention. For example, asshown in FIG. 32B, the aperture 404 formed may be defined by three flaps408. Further, as shown in FIG. 32C, the aperture 404 may be defined by asemi-circular cut through the chest assembly 12, which forms one flap408. In addition, as shown in FIG. 32D, the aperture 404 may be definedby three flaps 408 and an open passage 410 formed where the three flaps408 contact each other. Moreover, as shown in FIG. 32E, the aperture 404may be defined by a star cut pattern with spacing between adjacent flaps408.

Referring back to FIGS. 28-29, at each electrode or sensor connectionpoint 400, the chest assembly 12 includes an electrode housing 412 onthe non-patient side of the chest assembly 16. The electrode housing 412may be constructed from an elastomeric rubber, or any other suitableelastomeric or plastic material. The electrode housing 412 may bethermally bonded to the chest assembly 12 or adhered to the chestassembly 12 with any suitable adhesive. The electrode housing 412contains an appropriately sized female void 414 for receiving the maleportion 416 of any conventional electrode or sensor 20. The electrodehousing 412 should be constructed from a suitable elastomeric materialso that the female void 414 will conform to different male portions 416of different shapes and sizes when such male portions 416 are insertedinto the female void 414. Accordingly, upon insertion of the maleportion 416, the female void 414 conforms such that the male portion 416is removably secured in the female void 414. Because of theaforementioned design and configuration of the chest assembly, the chestassembly can be used with many different electrodes or sensors 20 thatare used in the healthcare industry. In addition, to aid the health careprovider in attaching the chest assembly 12 to the patient, eachelectrode housing 412 is preferably appropriately color coded and/orcontains alphameric designations to correspond to the particularelectrode or sensor 20 attached to that electrode housing 412. Forexample, the electrode housings 412 may be labeled RL, LA, LL, RA, or Vwhen the chest assembly is intended for ECG use. In yet anotherembodiment the electrode housing 412 is not bonded to the chest assembly20 but is provided separately. In such an embodiment, the technician orhealth care provider setting up the equipment would press on theseparate electrode housings 412 when attaching the chest assembly 12 tothe electrode or sensor 20.

To connect a conventional electrode or sensor 20, the male portion 416of an electrode or sensor 20 is inserted or positioned through theaperture 404. As the electrode or sensor 20 is inserted through theaperture 404, the male portion 416 of the electrode or sensor 20deflects the flaps 408. The resilience of the flaps 408 cause the flaps408 to wipe against the male portion 416 and mechanically hold theelectrode or sensor 20 in the aperture 404 defined between the flaps408. The pattern of the aperture 404 allows for the deflection of theflaps 408 with minimal force applied during the insertion of the maleportion 416 of the electrode or sensor 20. The male portion 416 of theelectrode or sensor 20 causes deflection of the flaps 408 withoutplacing undue stresses on the ends of the flaps 408 which couldotherwise result in the flaps being torn or losing their resilientproperty. In addition, because the aperture 404 is formed through theelectrically conductive element or trace 39, electrical conductivity isobtained when the electrode or sensor 20 contacts the flaps 408.Further, when the electrode or sensor 20 contacts electricallyconductive elements or trace 39 via the flaps 408, the electricalsignals corresponding to physiological data of the patient pass from theelectrode or sensor 20 to the electrically conductive element or trace39, which, in turn, conveys the data to the body electronics unit 14.

The electrode or sensor 20 is inserted or positioned through theaperture 404 so that a base portion 418 of the electrode or sensor 20firmly abuts or contacts the electrically conductive elements or trace39. Thus, the electrical signals corresponding to physiological data ofthe patient pass from the electrode or sensor 20 to the electricallyconductive element or trace 39, which, in turn, conveys the data to theremote body electronics unit 14. Optionally an electrically layer oradhesive 402 may be used to enhance the mechanical and/or electricalconnection.

In another embodiment, as shown in FIG. 30, the chest assembly 12 may beconstructed such that a conductive male connector 420 to connect aconventional electrode or sensor 20 that has a female receptacle or void422, instead of a male portion 416 (as shown in FIG. 29). To connect theconventional electrode or sensor 20 having the female receptacle or void422, the conductive male connector 420 is inserted through the aperture404 until a first male member 424 is removably secured in the electrodehousing 412. The conductive male connector 420 contacts the electricallyconductive element or trace 39 upon insertion. The electrode or sensor20 having the female receptacle or void 422 is then removably connectedto a second male member 426. Alternatively, as shown in FIG. 31, themale conductive connector 420 may be integrally connected or fixedlysecured to the electrode housing 412. In such an embodiment, theelectrode housing 412 would not be constructed of elastomeric materialand would not contain the female void 424 (shown in FIGS. 28-30). Ineither case, the electrical signals corresponding to physiological dataof the patient pass from the electrode or sensor 20 to the conductivemale connector 420 and to the electrically conductive element or trace39.

Preferably, the chest assembly 12 and the electrodes or sensor used withthe chest assembly are constructed of radiolucent materials. Radiolucentelectrodes are known in the art and are sold by companies such as Kendleand 3M. In addition, the chest assembly 12 is designed and configured tobe used only a few times before being disposed. Accordingly, the chest12 is preferably constructed such that the electrodes or sensors 20 canbe connected to and disconnected from the chest assembly 12 only alimited amount of times before the connection between the chest assembly12 and the electrodes or sensor 20 becomes unusable and the chestassembly 12 must be discarded. For example, repeated use of theconnection and disconnection of the electrodes or sensors 20 to and fromthe chest assembly 12 may cause the electrically conductive element ortrace 39 to abrade or wear, the flaps 408 to lose their resilientproperty, or the elastomeric material defining the female void 414 tobecome overly stretched by the male portion 416. A disposable chestassembly 12 has many advantages. For example, disposable chestassemblies using the present invention offer hygienic advantages sincesuch chest assemblies will be disposed of after each patient use—thus,reducing the spread of infection or disease. Further, lead assemblies ofthe present design may be made radiolucent by selection of appropriatematerials thereby enabling their use in medical procedures wheretraditional snaps would interfere with imaging equipment. Further, thematerials used to construct a disposable chest assembly, which uses thepresent invention are significantly less expensive than the materialsused on other known disposable systems. Thus, the fastener assembly ofthe present invention makes a disposable chest assembly very costeffective compared to other known disposable systems.

Referring back to FIG. 1, the chest assembly 12 is capable of attachingto five electrodes 20 and provides a means for generally positioning theelectrodes on the patient, thereby providing up to a “7 lead” analysisof the electrical activity of the heart. The electrode connectors 18 arepreferably labeled and color-coded to ensure that the chest assembly 12is properly positioned on the patient and connected to the appropriateelectrodes 20. For instance, the electrode connectors are preferablylabeled RL, LA, LL, RA, and V, respectively. The chest assembly 12 isconstructed such that the RA electrode connector is connected to anelectrode positioned on the right side of the patient's chest aboutlevel of the first and second intercostal space, the LA electrodeconnector is connected to an electrode positioned on the left side ofthe patient's chest about level of the first and second intercostalspace, the RL and LL electrode connectors are connected to electrodespositioned on the left side of the patient's torso, and the V electrodeconnector is connected to an electrode positioned in the middle of thepatient's chest about level of the fourth and fifth intercostal space.The chest assembly 12 is preferably designed such that it is centered onthe chest below the patient's clavicle.

Referring to FIG. 3, the chest assembly 12 is configured to provideflexible positioning of the chest assembly 12 on the patient. FIG. 3 isfor illustrative purposes only, and thus, the chest assembly 12, asdepicted in FIG. 3, is not limited to any particular shape orconfiguration. The chest assembly 12 has a linear section or tail 46extending from the chest assembly connector 21. The tail 46 flows intoan electrode retaining section 47. The electrode retaining section 47has an arcuate section 48. A first expandable arm 50 attaches to thearcuate section 48. The RA electrode connector 18 a attaches to thefirst expandable arm 50. The arcuate section 48 flows into a transitionsection 52. The LA electrode connector 18 b attaches to the transitionsection 52. The transition section 52 flows into a linear run 54. The RLelectrode connector 18 c attaches to the linear run 54. A secondexpandable arm 56 and an extension arm 58 attach to the linear run 54.The V electrode connector 18 d attaches to the second extension arm 58and the LL electrode connector 18 e attaches to the second expandablearm 56.

The expandable arms 50, 56 are die cut in a serpentine pattern. Theexpandable arms 50, 56 comprise polypropylene or polyethylene fabric,Kapton, Mylar, or other flexible, memoryless material. The expandablearms 50, 56 expand, if necessary, by elongating the serpentine pattern.When expanded, a portion or all of the expandable arm is extended. Whereonly a portion of the expandable arm is extended, another portionremains folded. The expandable arms 50, 56 allow for extension as neededso that the chest assembly 12 can fit patients of various sizes and alsoallow for patient movement when the patient is wearing the chestassembly 12. The extension arm 58 allows for flexible positioning of theV electrode connector in the middle of the patient's chest such asplacement at electrode position V1, V2 or V3. In some instances, thehealth care practitioner may desire not to utilize the extension arm 58for taking electrocardiograph measurements. Thus, to keep the extensionarm 58 secured to the linear run 58 and to ensure that the extension arm58 will not interfere with the placement and positioning of the chestassembly 12, the extension arm 58 is die cut with a perforated seam thatconnects the extension arm 58 and the linear run 54 along the length ofthe extension arm 58. If the health care practitioner desires to use theextension arm 58, the perforated seam is unbroken so that the extensionarm 58 can be selectively positioned on the patient's chest.

In another alternative embodiment shown in FIG. 3A, the chest assembly12 may be configured such that the electrodes labeled RL, LA, and RA canpositioned straight across the patient's chest. Such an embodiment ispreferably used on an “out-patient” basis. The chest assembly 12 shownin FIG. 3A has a tail 46 that flows into an electrode retaining section47. The electrode retaining section may be configured to attach to threeelectrodes, namely the RL, LA, and RA electrodes. Preferably, the RLelectrode is positioned between the LA and RA electrodes. Expandablearms 56 connect the LA and RA electrodes to the RL electrode and allowfor extension as needed so that the chest assembly 12 can fit patientsof various sizes and also allow for patient movement when the patient iswearing the chest assembly.

Referring to FIG. 1, the chest assembly 12 can be used with a precordialassembly 60 to provide a “12-lead” analysis of the electrical activityof the heart. Similar to the chest assembly 12, the precordial assembly60 is a one-piece flexible circuit that connects a plurality ofelectrode connectors 62. The electrode connectors 62 have releasableconnections that connect to electrodes. Preferably, the electrodeconnectors 62 have snap terminals that connect to electrodes having snapterminals. Each electrode connector 62 connects to an electricallyconductive element or trace for transmitting electrical signals from apatient's heart. The electrically conductive elements or traces runalong the precordial assembly 60 and connect to a precordial assemblyconnector 66. The precordial assembly 60 may be constructed similarly tothe chest assembly 12 discussed above.

The precordial assembly 60 is capable of attaching to six electrodesselectively positioned on the abdomen and middle chest of the patient.The electrode connectors 62 of the precordial assembly 60 are preferablylabeled and color-coded so as to prevent a health care provider fromapplying or positioning the precordial assembly onto the patientimproperly. For instance, the electrode connectors 62 are preferablylabeled V1, V2, V3, V4, V5, and V6, respectively. When the precordialassembly 60 is used, the V electrode connector on the chest assembly 12is removed from its electrode and replaced with an electrode connectoron the precordial assembly 60.

As shown in FIG. 4, the precordial assembly 60 is configured to provideflexible positioning of the precordial assembly 60 on the patient. FIG.4 is for illustrative purposes only, and thus, the precordial assembly60, as depicted in FIG. 4, is not limited to any particular shape orconfiguration. The precordial assembly has a linear section or tail 68extending from the precordial assembly connector 66. The linear sectionor tail 68 flows into an electrode retaining section 69. The electroderetaining section 69 has a first arcuate section 70 having a firsttransition section 72. The V2 electrode connector 62 b attaches to thefirst transition section 72. The V1 electrode connector 62 a attaches toa first extension arm 74 connected to the first transition section 72. Asecond arcuate section 76 extends from the first transition section 72.A second transition section 78 abuts the second arcuate section 76 andthe V4 electrode connector 62 d attaches to the second transitionsection 76. The V3 electrode connector 62 c attaches to a secondextension arm 80 connected the second transition section 78. A thirdarcuate section 82 flows from the second transition section 78. Thethird arcuate section 82 abuts a third transition section 84. The V5electrode connector 62 e attaches to the third transition section 84. Afourth arcuate section 86 extends from the third transition section 84.The V6 electrode connector 62 f attaches to the fourth arcuate section86. The configuration of the precordial assembly 60 allows the healthcare provider or physician to flexibly position the electrode connectors62 as needed to properly situate the precordial assembly 60 on thepatient and to allow for patient movement when the patient is wearingthe precordial assembly 60.

In another alternative embodiment shown in FIG. 3A, the precordialassembly 60 may be configured such that the electrodes labeled V₁-V₆ canbe diagonally positioned in a row across the patient's chest. Such anembodiment is preferably used on an “out-patient” basis. The precordialassembly 60 shown in FIG. 3A has tail 68 that flows into an electroderetaining section 69. The electrode retaining section may be configuredsuch that the LL electrode is located at the end of the diagonal lineformed by the V₁-V₆ electrodes.

In operation, the chest assembly 12 and the precordial assembly 60detect electrical signals generated by the heart during each beat andtransfer these signals to the body electronics unit 14. When the systemis operating in “7 lead” mode (i.e. when only the chest assembly 12 isbeing used) the body electronics unit 14 acquires signals from the RL,RA, LL, LA, and V electrodes. The body electronics unit 14 uses the RLelectrode as a ground reference. When the system is operating in the “12lead” mode (i.e. the chest assembly 12 and the precordial assembly 60are being used) the body electronics unit 14 acquires signals from theRL, RA, LL, and LA electrodes via the chest assembly 12 and acquiressignals from the V1, V2, V3, V4, V5, and V6 electrodes via theprecordial assembly 60. Alternatively, a various number of electrodesmay be monitored by the system. For example, the health care provider orphysician may choose to use only two electrodes to monitor the heart,seven electrodes to monitor the heart, or the like. In other words, thepresent system is not limited to performing a “7 lead” and “12 lead”analysis of the heart. In addition, to detecting electrical signals fromthe heart, the chest assembly 12 and the precordial assembly 60 may beconstructed to detect other vital signs of the patient, for example,pulse, respiration rate, heart rate, temperature, blood pressure, EEGsignals, and pulse oximeter signals.

Referring to FIG. 5, the chest assembly 12 connects to the bodyelectronics unit 14 via a chest assembly connector 21. Specifically, thechest assembly connector 21 inserts into a chest assembly port 88located in the body electronics unit 14. Similarly, the precordialassembly 60 (not shown) connects to the body electronics unit 14 via theprecordial assembly connector 66 (not shown). Specifically, theprecordial assembly connector 66 (not shown) inserts into a precordialassembly port 90. Resisters are connected to the chest assembly port 88and the precordial assembly port 90 to prevent excessive electricalcurrent from entering the body electronics unit 14—thereby ensuring thatthe body electronics unit 14 continues to operate properly in thepresence a strong electrical current caused by a defibrillator (i.e. a 5kV defibrillation excitation). The chest assembly connector 21 and theprecordial assembly connector 66 are specifically keyed or configured toprevent the assembly connectors 21, 66 from being inserted into theassembly ports 88, 90 backwards, misaligned or otherwise improperly.Moreover, the chest assembly connector 21 is keyed or configured suchthat it is not compatible with the precordial assembly port 90.Likewise, the precordial assembly connector 66 is keyed or configuredsuch that it is not compatible with the chest assembly port 88.Specifically, the chest assembly connector 21 has tongues specificallyconfigured or arranged to fit into corresponding grooves of the chestassembly port 88. Accordingly, the chest assembly connector 21 can onlybe connected to the chest assembly port 88 in one orientation. Forexample, if the tongues are not aligned with the grooves, the chestassembly connector 21 will not couple to the chest assembly port 88.Likewise, the precordial assembly connector 66 has tongues specificallyconfigured or arranged to fit into corresponding grooves of theprecordial assembly port 90.

As shown in FIG. 6, the chest assembly connector 21 and the precordialassembly connector 66 (not shown) have retaining clips or flanges 92located on the sides of the connectors 21, 66 for removably securing theconnectors 21, 66 into the assembly ports 88, 90. However, other meansmay be used to removably secure the connectors 21, 66 in the assemblyports 88, 90, such as screws, pins or the like. In addition, theassembly connectors 21, 66 may have spring flanges or clips 94 locatedat the tip of the connectors 21, 66 for providing a bias or tensionagainst the assembly ports 88, 90. The spring flanges or clips 94provide the connectors 21, 66 with a secure fit within the assemblyports 88, 90, thereby reducing any play or movement of the connectors21, 66 within the assembly ports 88, 90. The electrically conductiveelements or traces are specifically configured on the connectors 21, 66so as to ensure that the electrical signals from the heart are properlytransmitted to the body electronics unit 14. In other words, theelectrically conductive elements or traces must be sufficiently spacedapart or otherwise isolated in some manner to prevent arcing across theelectrically conductive elements. In addition, the spacing of theelectrically conductive elements or traces permits the chest assemblyand the precordial assembly to withstand defibrillation shock.Furthermore, the connectors 21, 66 have ribs 96 for preventing theelectrically conductive elements or traces from coming into contact withmetal objects or the like when the connectors 21, 66 are not insertedinto the assembly ports 88, 90.

The chest assembly connector 21 may have a sensor pin or ground pin 98that completes a circuit within the body electronics unit 14 when thechest assembly connector 21 is plugged into the chest assembly port 88,thereby activating the power and bringing the body electronic unit 14out of “sleep mode.” The sensor pin has specific tongue that correspondsand fits into a groove located in the chest assembly port 88. The sensorpin 98 serves as a means for the body electronics unit 14 to identifythe chest assembly 12 and to prevent the use of other chest assembliesor electrocardiograph wearables that are not designed to be used withthe on-body electronic unit 14. In other words, the power of the bodyelectronics unit 14 will not activate unless the body electronics unit14 identifies or recognizes the sensor pin 98 of the chest assembly 12.Likewise, the precordial assembly connector 66 may also have a sensorpin or ground pin 98. Alternatively, the body electronics unit 14 mayhave a power activation switch to turn the power “on” and “off”independent of any sensor pin configuration.

The outside casing of the body electronics unit 14 is constructed oflightweight, molded plastic, such as acrylonitrile-butadiene-styrene(ABS) or other suitable material. The shape and configuration of thebody electronics 14 unit is not limited to any particular shape orconfiguration. As shown FIG. 1, the body electronic unit 14 removablysecures to the patient's arm via an armband 100, thus making the bodyelectronics unit 14 readily accessibly to the patient. The armband 100is capable of attaching to either the patient's right or left arm andattaches via Velcro or other suitable fastening means such as pins,snaps, or the like. Preferably, the body electronics unit 14 slidesunder a strap or pocket on the armband 100. Other means can be used tosecure the body electronics unit to the patient without departing fromthe spirit and scope of the invention. For example, the body electronicsunit 14 could be positioned in a pocket or pouch of patient gown, or apendent or strap around a patient's neck. Alternatively, the bodyelectronics unit 14 could also be secured to the bed or other bedsidemounting unit. Referring to FIG. 7, the body electronic unit 14 has auser interface 102 and a battery 104. The user interface 102 providesinformation to the patient pertaining to the system's operating statusor functionality. For example, an exemplary embodiment of the userinterface 102 may provide information on whether the body electronicsunit 14 is communicating or transmitting normally to the base station16, whether the battery 104 of the body electronics unit 14 is chargingor the battery 104 is low, whether the power of the body electronicsunit 12 is activated, or whether the body electronics unit 14 or basestation is malfunctioning. In addition, the user interface 102 mayprovide instructions on the correct order or procedure for pairing orcoupling the body electronics unit 14 with the base station 16. Suchinformation may be communicated to the patient via the user interface102 in various ways, for example, LEDs, LCD, text, audible tones, etc.An exemplary embodiment of the user interface is shown in FIG. 7A. Theuser interface 102 is readily accessible to the patient when the bodyelectronics unit 14 is secured to the armband 100.

The battery 104 is inserted into a battery port 106 located in thebottom of the body electronics unit 14. The battery 104 is retained inthe battery port 106 by latches or other suitable fastening means, suchas clips, screws or the like. The battery 104 is preferably a 3.6 VLi-ion rechargeable battery. The battery is preferably constructed tohave a charge indicator to indicate the amount of charge remaining inthe battery. The battery 104 is readily accessible to the patient whenthe body electronics unit 14 is secured to the armband 100.

The body electronics unit 14 controls the acquisition of the ECG signalsfrom the chest assembly 12 and the precordial assembly 60. A transmitterwithin the body electronics unit 14 receives or acquires ECG signalsfrom the chest assembly 12 and the precordial assembly 60 preferably at3 kbps. When the system is operating in “7 lead” mode (i.e. when onlythe chest assembly 12 is being used) the body electronics unit 14acquires signals from the RL, RA, LL, LA, and V electrodes. When thesystem is operating in the “12 lead mode” (i.e. the chest assembly 12and the precordial assembly 60 are being used) the body electronics unit14 acquires signals from the RL, RA, LL, and LA electrodes via the chestassembly 12 and acquires signals from the V1 thru V6 electrodes via theprecordial assembly 60. In addition, other vital signs of the patientmay be detected by the system and transmitted to the body electronicsunit 14, for example pulse, respiration rate, heart rate, temperature,blood pressure, EEG signals and pulse oximeter signals.

The detection of the respiration rate may be achieved by obtaining arespiratory cycle or respirogram from an impedance pneumograph signalthat is measured across two electrodes 20, for example the RA and LLelectrodes. The respiratory impedance may be measured by applying asinusoidal constant-current source between about 30 to 80 kHz across theelectrodes 20, preferably 39 kHz. The resulting voltage amplitude acrossthe electrodes at a given frequency is proportional to the transthoracicimpedance (i.e. Z=V/I, where I is a constant amplitude). The electrodesthat collect respiration rate data are also used to detectelectrocardiograph signals. Thus, the current invention is capable ofsimultaneously measuring a patient's respiration rate and cardiacactivity.

As shown in FIG. 7B, the body electronics unit 14 may include a currentsource 107A and a current source detection assembly that comprises adetection amplifier 107B, and a demodulator 107C to measure therespiratory impedance. In one embodiment, the current source 107 iscapacitor-coupled to the RA and LL signals after the defibrillationresistors. The current source 107A outputs a sinusoidal signal, forexample, a 68-μA sinusoidal signal, which passes through the RAelectrode, through the patient, and back through the LL electrode. Oneof ordinary skill in the art will recognize that other electrodes,besides the RA and LL electrodes, may be used. An example circuit, usingan operational amplifier to implement the current source 107A, is shownin FIG. 7C. By way of example, the maximum load impedance for thecurrent source 107A is 13.1 Kohm, which is based on a maximum outputvoltage of 2.5 Vpp or 0.89 Vrms. When the maximum load impedance is 4Kohm, the maximum value for the defibrillation resisters is 4.54 Kohm.

The detection amplifier 107B and the demodulator 107C process thecurrent source signal. The detection amplifier 107B provides ahigh-impedance buffer and gain for the signal. The demodulator 107Cconverts the amplitude-modulated signal to a low-frequency baseimpedance (˜1000 ohm) and an AC-coupled and amplified respirationimpedance signal (˜1 ohm pp). The respiratory impedance is split into abase impedance and a respiratory signal impedance to obtain moreresolution for the respiratory signal impedance. By way of example, thebase impedance signal may have a bandwidth of DC to 0.015 Hz while therespiration impedance signal has a bandwidth of 0.05 to 2.5 Hz. Thesesignals may digitized at a sample rate of 10 Hz. The digitized impedancesignals are then transmitted to the base station 16 for reconstruction.

As shown in FIG. 8, the transmitter may comprise an application specificintegrated circuit, a processor or other circuit, a plurality of signalchannels 112, a multiplexer 114, an analog-to digital converter (ADC)116, a controller 118, and a radio 120. Additionally, fewer or differentcomponents can be used. The body electronics unit 14 may have ten signalchannels 112 corresponding to the eleven electrodes connected to thechest assembly 12 and the precordial assembly 60. The electrode channels112 each comprise a connector 122, a filter 124, an amplifier 126, aNyquist filter 128 and a sample and hold circuit 130. The connectors 122of the signal channels 112 connect to either the chest assembly port 88or the precordial assembly port 90, depending on whether the electrodechannel 112 corresponds to an electrode located on the chest assembly 12or the precordial assembly 60. The filter 124 comprises a low passfilter, such as for removing electromagnetic interference signals. Theamplifier 126 amplifies the signals from the electrodes. The Nyquistfilter 128 comprises a low pass filter for removing out-of-band highfrequency content of the amplified signals to avoid sampling error. Thesample and hold circuit 130 enables the system to sample all nineelectrode channels signals 112 at the same or relatively same time sothat there is no differential error created when these signals arecombined later in the ECG monitor.

The multiplexer 114 sequentially selects signals from the electrodesignal channels 112 using time division multiplexing. One of ordinaryskill in the art, however, recognizes that other combination functionscan be used. The ADC 116 converts the combined analog signals to digitalsignals for transmission. Preferably the controller 118 comprises adigital signal processor (DSP) that decimates the digitized signals asto lessen the bandwidth required to transmit the signals. The DSP alsoperforms two-sample averaging and a thirty-tap Finite Impulse Response(FIR) digital low pass filter. The radio 120 modulates the digitalsignals with a carrier signal for transmission. In an exemplaryembodiment, the radio 120 includes a demodulator for receivinginformation. The controller 118 digitally transmits the ECG data to thebase station 16. In addition to transmitting ECG data, the controller118 may transmit signals pertaining to physiological andnon-physiological data such as token pairing information, pacemakerinformation, battery level information, electrode disconnectioninformation, and other information as required. For example, vital signssuch as pulse, respiration rate, heart rate, temperature, bloodpressure, EEG signals, and pulse oximeter signals may be transmitted.

The body electronics unit 14 continuously monitors the integrity of allpatient electrode connections. This function may be achieved bysupplying a direct current between all of the electrodes and the RLelectrode and measuring the DC impedance between all of the electrodesand the RL electrode. When any electrode becomes disconnected, a leadwire becomes broken, or the impedance between any individual electrodeand the RL electrode becomes very high, the voltage on that particularelectrode goes out of range. The body electronics 14 is capable ofdetecting the out of range voltage condition and sending a signal to thebase station which in turn causes the base station to trigger the “leadoff” alarm on the ECG monitor. Additionally, the body electronics unit14 has a self-test function that monitors the integrity of the primaryfunctions including the microprocessor, data acquisition, internalvoltage references, and radio functionality. In the event a failure isdetected, the body electronics unit will capture the fault condition,stop data acquisition and transmission and indicate that fault hasoccurred through the lead off alarm.

The body electronics unit 14 operates to minimize undesired noise orsignals. For example, components are matched such that later applicationto a differential amplifier in a legacy ECG monitor for determining aheart vector is accurate. ECG vectors are not formed by the ECG system10, but rather by the legacy ECG monitor. Because the ECG system 10 isessentially “in-series” with the legacy ECG monitor, any error mayproduce undesirable results. One potential source of error isdifferential error. This differential error can be observed on thelegacy ECG monitor when the ECG monitor forms the ECG lead signals bycombining the individual electrode signals in the ECG monitor inputstage. This input stage comprises a difference, or differential,amplifier to eliminate common mode interference from the signalsproduced at the electrodes 20.

An artifact will be present if there is any difference in how each ofthe electrode signals are processed when the legacy ECG's differentialamplifier forms the ECG lead signals or ECG vectors. For example, ifthere is a difference in the gain of the amplifier, a difference in thephase shift associated with the anti-aliasing (Nyquist) filters, or adifference in how the respective sample and hold circuits treat theelectrode signals, then this differential error creates an artifact onthe legacy ECG monitor. One important technique to minimize thispotential source of differential errors is to choose a Nyquist filtercutoff frequency that is very high. This is because each individualfilter will have differing group delay performance. To mitigate thatdifference, the frequency that this group delay will affect is muchhigher than the frequency of the ECG signals, which are about 0.05 Hz to150 Hz. By choosing a high cutoff frequency for the Nyquist filters, anymismatch in the Nyquist filter components will not affect the accuracyof the individual electrode ECG signals. For example, picking a filtercutoff frequency of 1,200 Hz mitigates this source of error. With thisapproach, the individual electrode ECG signals are over sampled at about3,000 Hz in order to not introduce aliasing. Of course higher filtercutoff frequencies and correspondingly higher sampling rates may furtherreduce error. Lower cutoff frequencies and/or sampling rate may be used.

Because the electrode signals are sampled at such a high rate, thesesignals may be decimated to minimize the required transmissionbandwidth. For example the digital samples are preferably decimated by afactor of eight in the controller of the body electronics unit 14.Greater or lesser rates of decimation can be used, such as decimation asa function of the bandwidth available for transmission, the number ofelectrode signals to be represented, and the Nyquist sampling rate. Thebase station 16 receives the transmitted signals sent from the bodyelectronics unit 14. The signals are transmitted as radio or othersignals modulated with a carrier signal. Various air-interfaces can beused for transmission, such as Bluetooth or IEEE 802.11b.

To establish proper communication between the body electronics unit 14and the base station 16, the base station 16 and body electronics unit14 need to be paired such that the base station 16 and the bodyelectronics unit 14 only recognize signals from its pair. This may beaccomplished in number of ways, for example, infra-red pairing ordirection connection pairing. Preferably, a token key 132 is used topair or radio frequency link the body electronics unit 14 and the basestation 16. Referring to FIGS. 9A and 9B, the token key 132 has memorychip and may optionally have a plurality of tongues or pins that fitwithin grooves located in a token key port 134 of the base station 16and within grooves of a token key port 136 of the body electronics unit14. To pair the body electronics u nit 14 with the base station 16, thetoken key 132 is inserted into the token key port 134 of the basestation and reads and records an identification number for the basestation 16. The token key 132 is then removed from the token key port134 and inserted into the token key port 136 located in the bodyelectronics unit 14. The electronics unit 14 receives the identificationnumber for the base station 16 from the token key 132. In turn, thetoken key 132 reads and records the identification number for the bodyelectronics unit 14. The token key 132 is then removed from the bodyelectronics unit 14 and reinserted into the token key port 134 of thebase station 16 whereby the base station 16 confirms the presence of itsown identification number on the token key 132 and also reads theidentification number for the body electronics unit 14 from the tokenkey 132. The body electronics unit 14 and the base station 16 arepaired. Alternatively, pairing or coupling can be accomplished by firstinserting the token key 132 into the body electronics unit 14, removingthe token key 132 and inserting the token key 132 into the base station16, removing the token key 132 and reinserting the token 132 into thebody electronics unit 14. In other words, the order in which the tokenkey 132 is inserted into the body electronics unit 14 and the basestation 16 is not critical to the proper operation of the system. Theuser interface 102 may provide the user or health care provider withinstructions on the correct order for pairing the body electronics unit14 with the base station 16. The use of the token key 132 allows thepairing function to occur while the body electronics unit 14 is worn bythe patient. This feature eliminates the need to disconnect andreconnect the body electronics unit 14 when a patient needs to beconnected to different ECG monitors as a result of being moved around ahospital. The patient's body electronics unit 14 is just repaired with anew base station using the token key 132.

After the body electronics unit 14 and the base station 16 are paired,the body electronics unit 14 and the base station 16 will remaincommunicating with each other as long as the token key 132 remains inthe token key port 134 of the base station 16 (or the token key port 136of the body electronics unit 14, depending on the order of the pairingprocess). In other words, as soon as the token key 132 is removed fromthe base station 16, the electronics unit 14 and the base station 16will discontinue or cease communication. Any specific token key 132 canbe used to pair any specific base station 16 with any specific bodyelectronics unit 14.

The ECG system can be configured such that the body electronics unit 14simultaneously communicates with more than one base station 16. In oneexemplary embodiment, a body electronics unit 14 can be configured tocollect and transmit diagnostic “7-lead” ECG signals to a first basestation 16 and collect and transmit diagnostic “12-lead” ECG signals toa second base station 16. More preferably, each body electronics unit 14may be configured with a temporary transmission mode that allows thebody electronics unit 14, which is already paired with and transmittingto a first base station 16, to temporarily pair with and temporarilytransmit ECG data to a second base station 16. Such a configuration willallow the health care provider to take a collect a temporary 12-lead ECGsignal measurement from a patient who is already on continuous 7-leadECG signal monitoring. To take the temporary 12-lead measurement, thehealth care provider will be required to attach the precordial assembly60 (the chest assembly 12 will already be attached for 7-leadmonitoring) to the body electronics unit 14 and the patient. A temporary12-lead mode switch on the body electronics unit 14 will be activatedbefore the health care provider pairs the body electronics unit 14 withthe second base station. The body electronics unit 14 and the secondbase station 16 will be paired in accordance with the pairing methoddiscussed above. Once the pairing is completed, the body electronicsunit 14 will begin to transmit 12-lead ECG data with the second basestation 16 while simultaneously transmitting 7-lead ECG data to thefirst base station 16. The body electronics unit 14 can be configured tosimultaneously transmit in the temporary mode for a sufficient,predetermined period of time to collect the 12-lead diagnostic ECGreading. Preferably, the body electronics unit 14 will be configured totransmit in the temporary mode for at least two minutes. After thepredetermined time period for temporary transmission has ended, the bodyelectronics unit 14 will stop transmitting to the second base station16.

The outside casing of the base station 16 is constructed of lightweight,molded plastic, such as acrylonitrile-butadiene-styrene (ABS) or othersuitable material. The shape and configuration of the base station 16 isnot limited to any particular shape or configuration. The base station16 is a portable transceiver that can be placed in any location and doesnot necessarily have to be placed or secured in any fixed location.Referring to FIG. 1, the base station 16 is preferably removably securedto an ECG monitor 138 via suitable mounting means, such as Velcro®,dual-lock strips, double-sided foam tape, or the like. Preferably, thebase station 16 is removably mounted to a mounting plate secured nearthe ECG monitor 138 via suitable mounting means. Alternatively, the basestation 16 can be incorporated into the monitor 138. As shown in FIG.10, the base station 16 has a cradle 140 for storing the bodyelectronics unit 14 when the body electronics unit 14 is not in use orotherwise off the patient. In addition, the base station 16 has abattery port 142 in which a base station battery 144 is removablyinserted. The base station 16 may be constructed to have a plurality ofbattery ports that store and charge batteries when the batteries are notbeing used. When the base station 16 is not plugged into an AC wallpower inlet, the base station battery 144 provides power to the basestation 16. When the base station 16 is operating on AC wall power, thebase station 16 charges the base station battery 144 when the basestation battery 144 is in the battery port 142. The base station 16 hasa power switch that activates/deactivates the power to the base station16 and a power cord connection 148 for connecting a power cord to an ACwall power inlet. The base station battery 144 is preferably a 3.6 VLi-ion rechargeable battery. Accordingly, the base station battery 144and the body electronics unit battery 104 are preferably identical andinterchangeable, such that each battery can be used in either the bodyelectronics unit 14 or the base station 16. The system is designed suchthat a discharged body electronics unit battery 104 is swapped for acharged base station battery 144. In this manner a charged battery isalways readily available for the body electronics unit. In addition, thebase station 16 has a lead switch that allows the health care providerto instruct the base station 16 to operate in “7 lead” mode or “12 lead”mode.

As depicted in FIG. 11, the base station 16 has a user interface 152that provides information to the health provider or patient pertainingto the system's operating status or functionality. For example, the userinterface 152 may provide information on whether the body electronicsunit 14 is communicating or transmitting normally to the base station16, whether the base station battery 144 is charging or the battery 144is low, whether the body electronics unit battery 104 is low, or whetherthe power of the base station 16 is activated, whether the base station16 is malfunctioning or otherwise requires servicing. In addition theuser interface 102 may provide instructions on the correct order orprocedure for pairing or coupling the body electronics unit 14 with thebase station 16. Such information may be communicated to the health careprovider or patient via the user interface 152 in various ways, forexample, LED's, LCD, text, audible tones, etc. An exemplary embodimentof the user interface 102 is shown in FIG. 11A.

Additionally, the base station has a self-test function that monitorsthe integrity of the primary functions including the microprocessor,data acquisition, internal voltage references, and radio functionality.In the event a failure is detected, the body electronics unit willcapture the fault condition, stop data acquisition and transmission andindicate that fault has occurred through the lead off alarm.

A receiver located within the base station 16 receives signals sent tothe base station 16 from the body electronics unit 14. As shown in FIG.12, the receiver includes a radio 156, a controller 158, adigital-to-analog converter (DAC) 160, a de-multiplexer 162, and aplurality of electrode signal channels 166. Additionally, fewer ordifferent components can be used. The radio 156 demodulates the receivedsignals for identifying digital data representing the combined electrodesignals. In an exemplary embodiment, the radio 156 includes a modulatorfor transmitting control information. The controller 158 controlsoperation of the various components and may further process the signalsfrom the radio 156, such as interpolating data, converting the signalsto digital information, generating control signals for the transmitterin the electronics unit 14, operating any user output or input devices,and diagnosing operation of the ECG system. Preferably, the controller118 interpolates the electrode signals to return the effective samplerate to about 3 kHz or another frequency. This enables thereconstruction filters to have a cutoff frequency many times thebandwidth of the electrode signals, thus minimizing any differences ingroup delay at the frequencies of interest, i.e. less than 150 Hz. TheDAC 160 converts the digital signals to analog signals. Thedemultiplexer 162 separates the individual regenerated electrode signalsonto the separate electrode signal channels 166. The receiver may have atransceiver that operates pursuant to the Bluetooth specification fortwo-way communication with the transmitter in the body electronics unit14.

The receiver may have nine electrode signal channels 166 correspondingto the ten electrodes. For continuous monitoring with only the chestassembly 12, the V electrode signal is output to the “V/V₁” terminal onthe receiver. For 12-lead ECG with both the chest assembly 12 andprecordial assembly 60, the V electrode signal is discarded and the V₁electrode signal is output to the “V/V₁” terminal on the receiver. Theelectrode signal channels 166 each comprise a sample and hold circuit168, a filter 170, and an attenuator 172. The sample and hold circuit168 is controlled by the controller 118 so that the converted electrodesignals appear simultaneously on each electrode signal channel 166.Other embodiments may include individual DAC's that provide the signalsubstantially simultaneously. The filter 170 comprises a low passreconstruction filter for removing high frequency signals associatedwith the DAC conversion process. The attenuator 172 comprises anamplifier for decreasing the amplitude to a level associated withsignals at the electrodes, which were earlier amplified in theamplifiers of the body electronics unit 14. This results in a unitysystem gain so as not to introduce error between the electrodes and theconventional ECG monitor.

Referring to FIG. 12A, the base station 16 may include a respirationnetwork 173 inserted in series with the electrode signal channel 166,that corresponds to the RA electrode, to reconstruct the digitizedimpedance signals sent from the electronics body unit 14. As depicted inFIG. 12B, the respiration network 173 may include digitally controlledresistors 173A and dual digital potentiometers 173B, one used for thebase impedance signal and one for the respiratory signal, in series withthe digitally controlled resistors. The base station 16 may furtherinclude a log taper potentiometer (not shown) to reduce the linearitycaused by using the digitally controlled resistors with the dual digitalpotentiometers.

Referring to FIG. 1, the base station 16 transmits the ECG signals andother physiological and non-physiological data to the ECG monitor 138via pre-existing or conventional monitor cables 174. In turn, theinformation is displayed on the ECG monitor and reviewed by a physician.As depicted in FIG. 13, the monitor cables removably insert onto snapterminals 176 located on the base station 16. Preferably, the basestation 16 has ten snap terminals 176 arranged on the left and rightside of the base station 16. The snap terminals 176 and the monitorcables are preferably labeled and color-coded so that the monitor cablesare properly connected to the base station 16. For instance, the fivesnap terminals 176 located on the left side of the base station 16 andthe monitor cable may be labeled as RL, LA, LL, RA, and V/V₁. Inaddition, the five snap terminals 176 on the right side of the basestation 16 and the monitor cable may be labeled V2, V3, V4, V5, and V6.When the ECG system is operating in “7 lead” mode (i.e. only the chestassembly 12 is used) the monitor cable is plugged into the five snapterminals 176 on the left side of the base station 16.

When the ECG system is operating in “12 lead” mode (i.e. both the chestassembly 12 and the precordial assembly 60 is used) both the monitorcables are plugged into the snap terminals 176—the top four snapterminals 176 on the left side of the base station 16 will be used forchest assembly electrodes and the remaining six snap terminals 176 willbe used for precordial assembly electrodes.

The ECG system of the present invention may be configured to monitor andtransmit pacemaker pulse information from the body electronics unit 14to the base station 16.

As described above, the body electronics unit 14 may have a plurality ofsignal channels 112 that are sampled to collect physiological data fromthe patient.

Preferably, there are ten channels. Three of the channels correspond tothe LA, RA, and LL electrodes and are sampled at 16 kHz. The sevenremaining channels correspond to the V and V₁-V₆ electrodes and aresampled at 4 kHz. The channels corresponding to the LA, RA, and LLelectrodes are sampled at a faster rate in order to detect fasttransients (i.e., pacemaker pulses) in the data from these channels.

Sampling of the plurality of signal channels 112 may be performed by aserial ADC. The ADC can be 16-bit converter. A bank or series ofmultiplexers select the channels for sampling. To sample the threechannels corresponding to the LA, RA, and LL electrodes at 16 kHz andthe remaining seven channels a 4 kHz, nineteen “virtual channels” arecreated. The virtual channels allow the system to perform nineteensamplings at 4 kHz, rather than three samplings at 16 kHz and sevensampling at 4 kHz. These virtual channels are four copies of each of thethree channels corresponding to the LA, RA and LL electrodes and onecopy of all the remaining channels corresponding to the V and V₁-V₆electrodes. The virtual channels are LA_(i), LA_(ii), LA_(iii), LA_(iv),RA_(i), RA_(ii), RA_(iii), RA_(iv), LL_(i), LL_(ii), LL_(iii), LL_(iv),V, and V₁-V₆. The order of and timing of the sampling of the signalchannels is depicted in FIG. 18.

Referring to FIG. 19, after sampling the nineteen virtual channels eighttimes each, a fist data set 200 is formed. The first data set 200 isreferred to as the raw data set. The data from the channelscorresponding to the LA, RA, LL electrodes is copied and reorganizedinto a second data set 202. The second data 202 set is referred to asthe snapshot data set. The snapshot data set is processed to identifyspikes in each lead (i.e., Lead I=LA-RA, Lead 2=LL-RA, Lead 3=LL-LA)that may be indicative of pacemaker pulses. To detect a pacemaker pulse,the differences between samples n and n-2 is calculated for each lead.If the differences between samples n and n-2 exceed a predeterminedthreshold value, the previous, current, and next snapshot data set arepackaged and transmitted to the base station 16. The three snapshot datasets total 6 ms of high-resolution data.

Before the raw data set can be transmitted to the base station 16, theraw data is averaged and filtered. Averaging and filtering reduces thegaussian-distributed noise inherent in the A/D conversion. In addition,averaging the raw data set provides a uniform sampling rate for allchannels before the data enters a series of Finite Impulse Response(FIR) filters. The channels corresponding to the LA, RA, LL electrodesundergo an 8-to-1 averaging and the channels corresponding to the V andV₁-V₆ electrodes undergo a 2-to-1 averaging to form raw data packets.

The raw data set that enters the averaging and filtering processrepresent 2 ms worth of data packets for all of the channels. The datapackets contain thirty-two samples of the channels corresponding to theLA, RA, LL electrodes and eight samples of the channels corresponding tothe V and V₁-V₆ electrodes. As depicted in FIG. 20, the averagingprocess converts the data packets into four samples of the ten channelsfor an effective data rate of 2 kHz.

After the data set is averaged, a unity-gain, 150-Hz low-pass filter isapplied to the data set. The low-pass-filtered data set then runsthrough two stages of FIR half band filtering and decimation. The 2 kHzof data is converted to 500 Hz. Four samples of each channel aredecimated to two samples (2 kHz to 1 kHz) and then decimated from twosamples to one sample (I kHz to 500 Hz). The 500 Hz data has a maximumun-aliased frequency of 250 Hz and has been low passed filtered by 150Hz to eliminate any possibility of aliasing. FIG. 21 depicts thefiltering process.

After decimation, the raw data set is ready for packaging andtransmission via Bluetooth. Each data point represents 2 ms of data (500Hz sampling). The maximum frequency that this data can represent is 250Hz and the data has been filtered to reject frequencies above 150 Hz.The raw data set and the snapshot data set are packaged for transmissionto the base station 16 via Bluetooth transmission as depicted in FIG.22. The raw data set and the snapshot data set are packaged into rawdata set packets and snapshot data set packets. Each data packet has apacket ID so that the raw data set and the snapshot data set can beproperly paired at the base station 16

The raw data packet transmitted from the body electronics unit 14 isinterpolated and duplicated at the base station 16. Two FIR interpolatedfilters convert one sample of raw data into four samples. FIG. 23depicts the FIR interpolation process. The data for each of the channelscorresponding to the LA, RA, LL electrodes are duplicated eight times tocreate thirty-two samples (2 ms of data at 16 kHz playback rate). Datafor each of the channels corresponding to the V and V₁-V₆ electrodes areduplicated two times to create eight samples (2 ms of data at 4 kHzplayback rate). With regard to the data corresponding to the V/V₁channel, the base station 16 receives one channel of data thatrepresents either the data from the V electrode or data from the V₁electrode. The base station 16 has a single port allocated to this data,regardless of whether the data is from the V electrode or the V₁electrode. To preserve the same sequence and timing on D/A playback, twovirtual channels are created from the single channel corresponding tothe V/V₁ electrodes. The data for the V/V₁ channel is copied to create aV channel and V₁ channel. FIG. 24 depicts the duplication of theinterpolated data.

The snapshot data set can be placed into the interpolated raw data toform a reconstructed, high-resolution waveform. After the raw datapacket is interpolated and duplicated, the ID of that raw data packet iscompared with the next available snapshot data packet. If the ID fromthe raw data packet matches the ID from the snapshot data packet, theraw data corresponding to the LA, RA, LL electrodes is overwritten withthe data contained within the snapshot data set. If the ID from the rawdata packet matches the ID from the snapshot data packet does not match,the snapshot data packet is considered out of sync and rejected orerased. FIG. 25 depicts the restoration of the pacemaker pulse.

The channels corresponding to the to the LA, RA, and LL electrodes areplayed out on the DAC at 16 kHz and the remaining channels correspondingto the V and V₁-V₆ electrodes are played out on the DAC at 4 kHz. Theplayback occurs in the same way that the sampling occurred at the bodyelectronics unit 14. FIG. 26 depicts the sequence and timing in whichthe nineteen virtual channels are played out.

There may be instances where a base station 16 will not be in every wardor hospital room for use with the body electronics unit 14. In suchinstances, an adapter assembly 178 may be used to connect the chestassembly 12 or the precordial assembly 60 to the ECG monitor 138. In oneexemplary embodiment, the adaptor assembly 178 allows the chest assembly12 or precordial assembly 60 to be plugged directly into a conventionalor existing telemetry transmitter. FIG. 14 depicts the adapter assembly178 having an assembly receptacle 180 that connects to the chestassembly 12 (not shown) or the precordial assembly 60 (not shown) and atelemetry box receptacle 182 that connects to a conventional or existingtelemetry transmitter. In another exemplary embodiment, the adaptorassembly 178 allows the chest assembly 12 or precordial assembly 60 tobe plugged directly into a conventional or existing ECG monitor trunkcables. FIG. 15 depicts the adaptor assembly 178 having an assemblyreceptacle 184 for connecting to the chest assembly 12 (not shown) orthe precordial assembly 60 (not shown) and a cable assembly 185 forconnecting to a conventional or existing ECG monitor trunk cable. Thecable assembly 185 has a cable 186 that connects to a trunk cableadaptor 188 for connecting to an ECG monitor trunk cable. In anotherexemplary embodiment, the adaptor assembly 178 allows the chest assembly12 or precordial assembly 60 to be plugged directly into standard leadwires that connect to an ECG monitor. Various configurations of theadapter 178 are possible depending on the connector configuration of thestandard lead wires.

FIG. 17 depicts the method of monitoring the cardiac activity in thepatient's heart using the wireless ECG system of the present invention.In step 198, electrodes are placed on the patient's body. In step 200,the chest assembly 12 and/or precordial assembly 60 are positioned onthe patient's body by connecting the electrode connectors 21, 62 to theelectrodes. In step 202, the chest assembly 12 and/or the precordialassembly 60 are plugged into the body electronics unit 14. In step 204,the electronics unit 14 and the base station 16 are paired or coupled byinserting the token key 132 into the base station 16, removing the tokenkey 132 from the base station 16, inserting the inserting the token key132 into the body electronics unit 14, removing the token key 132 fromthe electronics unit 14, and reinserting the token key 132 into the basestation 16. Alternatively, coupling can be accomplished by inserting thetoken key 132 into the body electronics unit 14, removing the token key132 from the body electronics unit, inserting the token key 132 into thebase station 16, removing the token key 132 from the base station 16 andreinserting the token key 132 into the body electronics unit 14. In step206, electrical signals from the patient's heart are detected andtransmitted to the body electronics unit 14 via chest assembly 12 andthe precordial assembly 60. In step 208, the electrical signals from theheart are transformed by the body electronics unit 14 from analogsignals to digital signals. In step 210, the body electronics unit 14transmits the digital signals to the base station 16 via radiotransmission. In step 212, the base station 16 transforms the digitalsignals into analog signals. In step 214, the base station 16 transmitsthe analog signals to the ECG monitor 138 via monitor cables 174. Instep 216, the ECG monitor 138 processes the analog signals intomeaningful information that can be displayed on the monitor 138.

As described above, various air-interfaces (e.g., Bluetooth or IEEE802.11b) can be used for transmitting the physiological andnon-physiological data from the body electronics unit 14 to the basestation 16. Preferably, the technology used for the signal transmissionbetween the body electronics unit 14 and the base station 16 is based onthe Bluetooth specification for two-way communication. The Bluetoothradio system, depicted in FIG. 27, consists of a radio unit 300, a linkcontrol unit 302, and a support unit 304 for link management and hostterminal interface functions.

The Bluetooth system may provide a point-to-point connection (only onebody electronics unit 14 and one base station 16 involved), or apoint-to-multipoint connection (when multiple body electronics units 14and base stations 16 are involved). In the point-to-multipointconnection, the transmission channel is shared among several electronicsunits 14 and base stations 16. When an electronics unit 14 and a basestation 16 share the same channel, a “piconet” is formed. In such anembodiment, the base station 16 performs as the master of the piconet,and the electronics unit 14 performs as the slave.

Up to seven slaves can be active in a piconet. Many more slaves,however, can remain locked to the master in a so-called parked state.These parked slaves cannot be active on the channel, but remainsynchronized to the master. Both for active and parked slaves, thechannel access is controlled by the master. Each piconet can only have asingle master. However, slaves can participate in different piconets ona time-division multiplex basis. In addition, a master in one piconetcan be a slave in another piconet. The piconets shall not be time orfrequency synchronized. Each piconet has its own hopping channel.

The radio 300 uses a spread spectrum, frequency hopping, full-duplexsignal at up to 1600 hops/sec. The signal hops among the radio frequencychannels at 1 MHz intervals to provide a high degree of interferenceimmunity. Information is exchanged through packets. Each packet istransmitted on a different hop frequency. A packet nominally covers asingle slot (e.g., 1 MHz bandwidth), but can be extended to cover up tofive slots. Bluetooth can support an asynchronous data channel (e.g.,one direction), up to three simultaneous synchronous voice channels, ora channel, which simultaneously supports asynchronous data andsynchronous voice. The asynchronous channel can support maximal 723.2kb/s asymmetric (and still up to 57.6 kb/s in the return direction), or433.9 kb/s symmetric.

The channel is represented by a pseudo-random hopping sequence hoppingthrough the radio frequency channels. The hopping sequence is unique forthe piconet and is determined by the Bluetooth device address of themaster (e.g., each base station 16 has a transceiver that is allocated aunique 48-bit Bluetooth device address). The phase in the hoppingsequence is determined by the Bluetooth clock of the master. The channelis divided into time slots where each slot corresponds to an RF hopfrequency. Consecutive hops correspond to different RF hop frequencies.The nominal hop rate is 1600 hops/s. All Bluetooth units participatingin the piconet are time and hop synchronized to the channel.

Each time slot is 625 μs in length. In the time slots, the master (ie.,the base station 16) and slave (ie., the body electronics unit 14) cantransmit packets. A time division duplexing (TDD) scheme is used where amaster and a slave alternatively transmit in a synchronous manner. Themaster shall start its transmission in even numbered time slots only,and the slave shall start its transmission in odd numbered time slotsonly. The packet start shall be aligned with the slot start. Packetstransmitted by the master or the slave may extend over or up to fivetime slots. Due to packet types that cover more than a single slot,master transmission may continue in odd numbered slots and slavetransmission may continue in even numbered slots.

The RF hop frequency shall remain fixed for the duration of the packet.For a single packet, the RF hop frequency to be used is derived from thecurrent Bluetooth clock value. For a multi-slot packet, the RF hopfrequency to be used for the entire packet is derived from the Bluetoothclock value in the first slot of the packet. The RF hop frequency in thefirst slot after a multi-slot packet shall use the frequency asdetermined by the current Bluetooth clock value. If a packet occupiesmore than one time slot, the hop frequency applied shall be the hopfrequency as applied in the time slot where the packet transmission wasstarted.

The hoping sequence selection procedure consists of selecting a sequenceand mapping this sequence on the hop frequencies. The type of sequenceselected mostly depends on the state of the devices communicating.

Every Bluetooth unit has an internal system clock, which determines thetiming and hopping of the transceiver. The Bluetooth clock is derivedfrom a free running native clock, which is never adjusted and is neverturned off. For synchronization with other units, only offsets are usedthat, added to the native clock, provide temporary Bluetooth clockswhich are mutually synchronized. It should be noted that the Bluetoothclock has no relation to the time of day; it can therefore beinitialized at any value. The Bluetooth clock provides the heart beat ofthe Bluetooth transceiver. Its resolution is at least half thetransmission or reception slot length, or 312.5 μs. The clock has acycle of about a day.

The timing and the frequency hopping on the channel of a piconet aredetermined by the Bluetooth clock of the master. When the piconet isestablished, the master clock is communicated to the slaves. Each slaveadds an offset to its native clock to be synchronized to the masterclock. Since the clocks are free running, the offsets have to be updatedregularly. This offset is updated each time a packet is received fromthe master: by comparing the exact receiver timing of the receivedpacket with the estimated receiver timing, the slaves correct the offsetfor any timing misalignments.

Frequency hopping is accomplished with the use of a fast settling phaselocked loop (PLL). Since Bluetooth hops up to 1600 hops/second, the PLLremains on a channel only 625 μs, which means that the PLL lock time canbe only a fraction of this, or else the system will be waiting too longfor the PLL to switch frequencies and the data rate will be too slow.Therefore, typically, after a 220 μs settling delay, the voltage controloscillator (VCO) of the PLL is locked and is at the prescribed RF hopchannel. The RF output of the VCO is used as a local oscillator.

The data transmitted has a symbol rate of 1 Ms/s (mega sample persecond). A Gaussian-shaped, binary frequency shift keying (FSK)modulation is applied with a bandwidth bit-duration (BT) product of 0.5.A binary one is represented by a positive frequency deviation, and abinary zero is represented by a negative frequency deviation. Themaximum frequency deviation shall be between 140 kHz and 175 kHz. Themodulation index must be between 0.28 and 0.35.

The bit ordering when defining packets and messages follows the LittleEndian format (i.e., the least significant bit (LSB) is the first bitsent over the air and in illustrations, the LSB is shown on the leftside). Furthermore, data fields generated internally, such as the packetheader fields and payload header length, are transmitted with the LSBfirst. The data on the piconet channel is conveyed in packets. Eachpacket consists of 3 entities: the access code, the header, and thepayload. The access code and header are of fixed size: 72 bits and 54bits respectively. The payload can range from zero to a maximum of 2745bits. Each packet starts with an access code. If a packet headerfollows, the access code is 72 bits long; otherwise the access code is68 bits long.

This access code is used for synchronization, DC offset compensation,and identification. The access code identifies all packets exchanged onthe channel of the piconet: all packets sent in the same piconet arepreceded by the same channel access code. In the receiver of theBluetooth unit, a sliding correlator correlates against the access codeand triggers when a threshold is exceeded. This trigger signal is usedto determine the receive timing.

Before transmission, both the header and the payload are scrambled witha data whitening word in order to randomize the data from highlyredundant patterns and to minimize DC bias in the packet. The scramblingis performed prior to field error control (FEC) encoding. At thereceiver, the received data is descrambled using the same whitening wordgenerated in the recipient. The descrambling is performed after FECdecoding.

After transmission, a return packet is expected N×625 μs after the startof the transmitter burst where N is an odd, positive integer. N dependson the type of the transmitted packet. To allow for some time slipping,an uncertainty window is defined around the exact receive timing. Duringnormal operation, the window length is 20 μs, which allows the receiverburst to arrive up to 10 μs too early or 10 μs too late.

In the foregoing specification, the present invention has been describedwith reference to specific exemplary embodiments thereof. It will beapparent to those skilled in the art, that a person understanding thisinvention may conceive of changes or other embodiments or variations,which utilize the principles of this invention without departing fromthe broader spirit and scope of the invention. The specification anddrawings are, therefore, to be regarded in an illustrative rather thanrestrictive sense. Accordingly, it is not intended that the invention belimited except as may be necessary in view of the appended claims.

1. A radiolucent assembly for collecting physiological data comprising:a substantially radiolucent base layer having a first side and a secondside, the first side attached to a plurality of substantiallyradiolucent electrically conductive elements, the electricallyconductive elements configured to be coupled to electrodes; said baselayer disposed adjacent at least one insulating layer.
 2. The assemblyof claim 1 wherein said base layer is disposed between a firstinsulating layer and a second insulating layer.
 3. The assembly of claim1 wherein said electrically conductive elements connect to at least oneelectrode connector and an assembly connector.
 4. The assembly of claim1 wherein the electrically conductive elements are printed ink oranisotropic adhesives.
 5. The assembly of claim 1 wherein theelectrically conductive elements are silver epoxy.
 6. The assembly ofclaim 1 further comprising a substantially radiolucent shielding layer.7. The assembly of claim 1 wherein one side of the assembly furthercomprises a fabric layer.
 8. The assembly of claim 6 wherein saidsubstantially radiolucent shielding layer comprises at least one layerof dielectric material.
 9. The assembly of claim 3 wherein each of saidplurality of electrically conductive elements form and define a separateelectrode.
 10. The assembly of claim 3 wherein said electrode connectorcomprises at least one aperture for receiving a portion of an electrode.11. The assembly of claim 10 further comprising: at least one electrodehousing disposed adjacent to said aperture, said electrode housingcontaining an elastomeric member that defines a female void forreceiving a conductive member of an electrode or sensor and wherein saidelectrode housing is substantially radiolucent.
 12. The assembly ofclaim 10 wherein said aperture forms at least one flap for engaging andsecuring the male portion of an electrode positioned through theaperture.
 13. The assembly of claim 10 wherein said female voidaccommodates a plurality of different sized male portions ofconventional electrodes.
 14. The assembly of claim 11 wherein saidelastomeric member securely retains the male portions of conventionalelectrodes.
 15. The assembly of claim 12 wherein said elastomeric memberremovably retains the male portions of conventional electrodes.
 16. Theassembly of claim 1 wherein the assembly connects to a telemetrytransceiver via an adapter assembly.
 17. The assembly of claim 1 whereinthe assembly connects to an electrocardiogram monitor via an adapterassembly.
 18. The assembly of claim 1 wherein the assembly isdisposable.
 19. The assembly of claim 1 wherein the assembly connectorcomprises a sense pin for turning electronics on.
 20. A radiolucentassembly for collecting physiological data comprising: a substantiallyradiolucent base layer having a first side and a second side, the firstside attached to a plurality of radiolucent electrically conductiveelements, the electrically conductive elements configured to be coupledto electrodes; said electrically conductive elements disposed adjacentat least one insulating layer, wherein the assembly is configured forplacement on the periphery of the torso leaving the torso relativelyunobstructed to allow access for treatment.
 21. The assembly of claim20, wherein the assembly is configured to lie predominantly on one sideof a patient's torso.
 22. The assembly of claim 20 wherein the assemblyhas expandable arms for placement of at least one of the right arm,right leg, left leg or left arm electrodes.
 23. The assembly of claim 20wherein one side of the assembly further comprises a fabric.
 24. Aradiolucent precordial assembly for collecting physiological datacomprising: a substantially radiolucent base layer having a first sideand a second side, the first side attached to a plurality of radiolucentelectrically conductive elements, the electrically conductive elementsconfigured to be coupled to a plurality of precordial electrodes throughan electrode connector; said electrically conductive elements disposedadjacent at least one insulating layer, wherein the assembly comprises aplurality of arcuate sections wherein the ends of each arc contain anelectrode connector, thereby allowing flexible placement of theprecordial electrodes.
 25. The precordial assembly of claim 24 whereinthe assembly further comprises a fabric layer.
 26. A method ofmonitoring a patient in need of radiography studies comprising:attachment to the patient of at least one substantially radiolucentelectrode, Attachment to the electrode, a chest assembly having asubstantially radiolucent base layer having a first side and a secondside, the first side attached to at least one substantially radiolucentelectrically conductive element, the electrically conductive elementsconfigured to be coupled to said electrodes; said base layer disposedadjacent at least one insulating layer, to the electrodes; the chestassembly further having a connector for attachment to an ecg monitor;Connecting the connector for attachement to to the ECG monitor; andmonitoring the patient.